It is a moment of gratification and pride to look back with a sense of contentment at the long travelled path, to be recapture some of the fine moments, to be able to thank infinite number of people, some who were with me from the beginning, some who joined me at some stage during the journey, whose kindness, love and blessing has brought this day, I wish to thank each one of them with all my heart.
My Sincere and wholehearted thanks and gratitude to our beloved and respected Principal Dr.
V.R. Aralelimath sir for his excellent guidance, critical supervision, keen interest and continuous encouragement throughout this study. His active guidance helped me to develop skills and insight in research and scientific presentation.
There are no proper words to convey my deep gratitude and respect for my thesis and research guide respected Dr. S. V. Patil sir, Asso. Prof, Dept. of Pharmaceutics, of Shree Santkrupa College of Pharmacy Ghogaon. He has inspired me to become an independent researcher and helped me realize the power of critical reasoning.
During my tenure, he contributed to a rewarding graduate school experience by giving me intellectual freedom in my work, supporting my attendance at various conferences, engaging me in new ideas, and demanding a high quality of work in all my endeavors.
I express my thanks to all teaching staff for their guidance and advice. I express my thanks to all non-teaching staff of Shree Santkrupa College of pharmacy, Ghogaon, who were always at front in providing any necessary requirements.
Friendship is wonderful gift that no one can buy. So, let me take this opportunity to thank all my friends, who are always there with me. My special ones Rohan, Suraj , Nitin, Ganesh, Govind made my time here at college a lot more fun and providing me moral support at all steps of my research work.
I am thankful to Aarti Chemicals, Mumbai for providing me sample of Lisinopril. I am also grateful to Loba Chemicals. Pvt. Ltd., Mumbai for providing all chemicals for my research work .I am also highly indebted to Govt. College of pharmacy, Karad for providing me lab. Characterization & library facilities for my dissertation work.
I should distinguishingly express my sincere thanks to my Husband Mr. Rohit Rasal for his moral support, intense interest and enthusiastic encouragement. I extend my thanks to Miss. Snehal Chakorkar for being so supportive and helpful.
Finally, and most importantly I extend a deep expression of gratitude to my Father (Vijay Rakshe) and my mother (Surekha Rakshe). My parents made numerous personal and professional sacrifices over the year to give me the opportunities that they never had. Their generous unwavering support allowed me to pursue my dreams. I am truly blessed to have such wonderful parents. The credit of this work goes to you Aai &Pappa, without your valuable support I am nothing. I would like to thanks all my relatives, friends and well-wishers their constant love and support that has allowed me to flourish & achieve all that I am. I love you all.!
In recent advancement, Modified dosage form such as controlled release, sustained release and extended release dosage formulations improve way of therapeutic treatment, improve patient convenience and compliance toward drug therapy. Recent studies shows that number of normal body function and disease condition show chronobiological behavior. The diseases which shows circadian rhythm dependency include asthma, peptic ulcers, cardiovascular ailments, arthritis and attention deficit syndrome in children and hypercholesterolemia. These diseases can be treated by advanced drug delivery system called ‘Pulsatile drug delivery system’ (PDDS).This system is designated in a manner to deliver drug in Pulse after predetermined lag time to match circadian rhythm of particular disease..
The main objective of present investigation is to formulate Bioadhesive pulsatile release tablet of Lisinopril drug belong to antihypertensive category .The concept behind this dosage form development is to investigate effect of coating polymer concentration on lag time and drug release from directly compressed tablet and to perform in -vitro dissolution study of prepared formulation.
Material and Method: Lisinopril was received as a gift sample from Aarti Chemicals, Mumbai. All the excipients such as croscarmellose sodium, HPMC K100, Carbopol, magnesium treated, mannitol were procured from Loba Chemicals, Mumbai. The method applied for Bioadhesive pulsatile release tablet was direct compression method. Bioadhesive pulsatile release tablet was characterized for bulk density , tapped density, angle of repose, Disintegration time, FTIR Studies, weight variation, Mucoadhesion strength,Hardness, Friability, Stability studies, and in-vitro drug release study.
The FTIR spectra revealed that there was no interaction between drug and excipient. The prepared Bioadhesive pulsatile release tablets showed desired hardness and good mucoadhesion strength. The obtained results showed the capability of formulated bioadhesive pulsatile drug delivery systems in a drug release for a programmable period of time to attain drug release after 3 hrs. lag time.
Conclusion: From formulated dosage form it is observed that the increasing or decreasing concentration of coating polymer blend had an effect on drug release. As the concentration of polymer blend increases, the lag time also increases and vice versa.
In in vitro drug release studies, it is concluded that compression coated tablets with HPMC K 100 M were satisfactory in terms of drug release after a predetermined lag time of 3 hrs. Stability study showed there is no any significant change in physical appearance, post-compression parameters and in vitro dissolution profile of compressed, coated tablets after one month.
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